Behind Paxil's black box

July 20, 2008 

Nortin Hadler's book tells how Americans are overtreated and alludes to the power of the big pharmaceutical companies in creating this situation. In "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial," Alison Bass tells a disturbing story of deception and possible fraud by companies, doctors and public officials charged with keeping Americans healthy and safe.

In this well-told story, Big Pharma uses Big Money to encourage Big Slick University Doctor to spin the results of Big Drug trial data while the FDA -- funded in part by Big Pharma -- looks the other way. In the story, Big Pharma is GlaxoSmithKline; Big Money is (among other payments) an $800,000 research grant; Big Slick University Doctor is Martin Keller of Brown University; and the Big Drug is Paxil, a hugely popular and profitable antidepressant. The spin? Paxil, it seems, causes suicidal thoughts in some children and pushes others to actually do it. This fact is discovered in a clinical trial but kept quiet. A few whistle-blowers uncover what's going on. They are harassed and intimidated but survive to see the story end.

Paxil is still being marketed by Glaxo. But, thanks to the whistle-blowers, every prescription of every antidepressant must now carry a so-called black-box warning stating that these drugs increase the risk of suicidal thinking and behavior in depressed children and adolescents. Furthermore, as part of a settlement of a lawsuit brought by the attorney general of New York, Glaxo was required to disclose all results -- including negative ones -- of all clinical drug trials. Congress has now extended that mandate to the clinical trials of all drugmakers.

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